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FDA Lifts Clinical Hold on Curis Cancer Drug, Shares Surge

Curis’ cancer drug just got a second lease on life. Now the Lexington, MA-based company will have to make something of it.

Curis (NASDAQ: CRIS) said today that the FDA has lifted the partial clinical hold on CUDC-427, the experimental cancer drug it licensed from Genentech a few years ago. The FDA’s decision takes CUDC-427 out of limbo; Curis can now go ahead and proceed with the early-stage trial it had been running before it was slapped with the partial hold in November.

Shares of Curis surged about 21 percent in pre-market trading on Monday before fading back to a roughly 11 percent gain.

“We have worked diligently with the FDA and anticipate re-opening of the monotherapy Phase 1 study as soon as possible,” Curis’ president and chief operating officer, Ali Fattaey, said in a statement.

Curis picked up CUDC-427 in November 2012 when it paid South San Francisco-based Genentech $9.5 million up front and lined up $30 million in debt financing from a fund managed by New York-based Pharmakon Advisors to move the program forward. The experimental drug is supposed to block proteins that help cancer cells avoid apoptosis, or programmed cell death.

Curis kicked off a Phase 1 trial of CUDC-427 in the third quarter of 2013, evaluating the drug in patients with advanced and refractory solid tumors or lymphomas and trying to find the right dose to use in a mid-stage study. But that effort came to a screeching halt in November due to safety concerns. The liver enzymes of one patient in the trial spiked under treatment, and didn’t subside after discontinuing the drug. That patient suffered liver failure about a month later and died. The FDA promptly froze the CUDC-427 study. Shares of Curis plummeted.

Genentech saw troubling signs in an early study of CUDC-427, before it licensed the drug to Curis—a few patients saw their liver enzyme levels increase during that Phase 1 trial. Curis has said, however, that that didn’t lead to any serious health problems.

Curis couldn’t restart its trial until it gave the FDA detailed data about all patients treated with CUDC-427, and submitted a protocol amendment that the agency agreed with. Though the hold has now been lifted, Curis didn’t detail how it plans to change the study. Curis wants to test CUDC-427 as a monotherapy, and in tandem with capecitabine (Xeloda) in patients with certain types of breast cancer.

Curis’ only approved drug also comes from a deal with Genentech. It worked together with Genentech on vismodegib (Erivedge), a treatment for a common form of skin cancer called basal cell carcinoma. The company is about to give investors a look at some of its other prospects shortly, however. Curis will present some data from its early studies of CUDC-427 and a few other in-house drug candidates at the American Association for Cancer Research’s annual meeting in early April.

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com Follow @benthefidler